The share of AbbVie’s brand-name version of Humira has dropped to 82% of the total market, 13% less than in March, according to a Samsung report published Thursday.
The cracks in AbbVie’s once-impregnable armor have come mostly from a partnership between Sandoz and CVS’ private-label drug unit Cordavis. CVS’ move in September to start preferring Sandoz’s Hyrimoz has given the drug 13% of the market.
But according to Samsung’s latest quarterly report, the other nine Humira biosimilars have captured just 5% of the total market.
The issue isn’t price. Nine of 10 Humira biosimilars now have list prices that are at least 80% less than AbbVie’s brand-name version, and six biosimilars are priced at an 85% or better discount.
In addition to Cordavis, the report notes how Intermountain Healthcare’s Scripius plans to remove brand-name Humira from its formularies for all commercial business on Oct. 1. Other PBMs and insurers may follow suit and remove Humira from more formularies, opening more space for biosimilars.
The market for Humira and its competitors is one of the biggest examples of the complicated relationship between brand-name drugmakers, PBMs and biosimilar competitors, which is coming under increasing scrutiny in Washington, but also by employers who pay for the benefits. Earlier this week, the FTC released an interim report looking at PBM practices that hinted at further scrutiny of those relationships in the future.
Samsung’s new report also digs into the FDA’s recent shift on interchangeability, opening it up for more biosimilars without conducting switching studies.
For Boehringer Ingelheim’s Humira biosimilar Cyltezo, the first interchangeable exclusivity dates were determined as 18 months from the approval date, Samsung explains, but separate dates were assigned to different strengths. The last of that exclusivity expired last September, according to the report, and moving forward, the FDA is looking to eliminate the statutory distinction between biosimilars and interchangeable biosimilars.
The small shares for the vast majority of Humira biosimilar developers show how this market may be too crowded. Coherus BioSciences recently announced the sale of its Humira biosimilar for just $40 million, only three years after it won FDA approval.